BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2180486 · Received July 27, 2011

    Report

    Report Number
    2050012-2011-03751
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 26, 2011
    Report Date
    June 26, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT DISCREPANT BRAIN NATRIURETIC PEPTIDE (BNP) RESULTS FOR FIVE (5) PATIENT SAMPLES ON THEIR UNICEL DXC 600I SYNCHRON CHEMISTRY ANALYZER. THE PATIENT RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO IMPACT TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER HAD ASSAYED THE SAMPLES ON AN ANALYZER WITH CLOSED SPECIMEN TUBE ACCESS CAPABILITY. THE BNP RESULTS GENERATED BY THAT ANALYZER WERE DISCREPANT. THE CUSTOMER RE-ASSAYED THE SAME SAMPLES ON A DIFFERENT ANALYZER WITHOUT CLOSED SPECIMEN TUBE ACCESS CAPABILITY. THE BNP RESULTS GENERATED BY THAT ANALYZER WERE INTERPRETED TO BE CORRECT AND WERE REPORTED OUT OF THE LABORATORY. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE PERFORMED A SYSTEM CHECK ON THE ANALYZER (WITH CLOSED SPECIMEN TUBE ACCESS CAPABILITY) AND OBSERVED THAT THE ANALYZER FAILED THE CARRYOVER TEST FOR CLOSED SPECIMEN TUBE ACCESS. THE FSE REPLACED THE WASH PUMP ASSEMBLY AND PERFORMED A PREVENTIVE MAINTENANCE. SUBSEQUENTLY, THE CARRYOVER TEST PASSED PERFORMANCE SPECIFICATIONS. PRECISION RUNS OF FIVE (5) REPLICATES FOR EACH PATIENT SAMPLE YIELDED ACCEPTABLE RESULTS. OTHER ASSAYS ON THE ANALYZER WERE NOT IMPACTED BY THIS EVENT. THE BNP REAGENT USED BY THE CUSTOMER WAS MANUFACTURED BY BIOSITE INCORPORATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® CHEMISTRY ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 BNP REAGENT (BIOSITE INCORPORATED)